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The purpose of this research study is to evaluate a decision aid to help women aged 70 and older decide on treatment for their breast cancer.
The investigators aim to use this information to further refine and evaluate a decision aid to help newly-diagnosed women aged 70 and older with breast cancer understand the risks and benefits of different types of breast cancer treatment. The Decision Aid (DA) was created for women 70 years or older diagnosed with ER+, HER2-, clinically LN-, 3cm or less breast cancers deciding on breast cancer treatment. The DA was designed considering the health literary, cognitive abilities, treatment outcomes, and competing health issues of older women. Phase I : \- The investigators will obtain and incorporate additional feedback on the DA from women 70 years or older who were diagnosed with breast cancer \> 6 months ago, their family members, and clinicians, so that the DA can be refined and evaluated by women who were recently treated for breast cancer but not newly diagnosed with breast cancer. Phase II \- The investigators plan to test the efficacy of the revised DA in a randomized control trial (RCT) of 230 diverse women 70 years or older newly diagnosed with ER+, LN-, HER2-, 3 cm or less breast cancer.
Age
70 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Start Date
July 1, 2016
Primary Completion Date
March 1, 2022
Completion Date
March 1, 2022
Last Updated
January 5, 2024
65
ACTUAL participants
Breast Cancer Treatment Decision Aid for women 70+
OTHER
Usual Care
OTHER
Lead Sponsor
Beth Israel Deaconess Medical Center
Collaborators
NCT05372640
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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